For consumers, personal sound amplification devices can boost sound that is too faint for most of us to hear. This technology can be used by consumers who want to temporarily heighten their hearing, including the use of headphones and equipment used to modestly boost the sound on telephones, listening devices and other audio amplification, and even to aid birdwatchers. These are low-cost devices are available over-the-counter in many stores like Walmart, Costco, Best Buy and elsewhere. They are typically a one-size-fits-all solution, and can be helpful for those with zero to modest hearing loss, including elderly consumers.
These technological devices are not substitutes for hearing aids, which can cost thousands of dollars, may include specific features and are typically personalized to fit patients’ ears. Hearing aids are medical devices recommended under the advisement of a licensed audiologist for patients with modest or severe hearing loss. Hearing aids are regulated by the Federal Drug Administration (FDA); personal amplification devices are regulated on the state level, not the FDA.
Now some members of Congress, led by Senator Elizabeth Warren, want to change this. They are pushing a bill that would permit the FDA to regulate over-the-counter personal amplification devices as part of a new hearing aid category. The stated purpose of this regulatory move is to spur technological innovation, reduce consumer costs and improve consumer access to these products — but nothing can be further from the truth…
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